UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050056 |
|---|---|
| Receipt number | R000057015 |
| Scientific Title | Elucidation of the neural basis of sensorimotor function using temporal interference stimulation |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/01/18 13:51:00 |
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Basic information
Public title
Elucidation of the neural basis of sensorimotor function using temporal interference stimulation
Acronym
Examination of brain activity related to sensory-motor function
Scientific Title
Elucidation of the neural basis of sensorimotor function using temporal interference stimulation
Scientific Title:Acronym
Examination of brain activity related to sensory-motor function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to investigate the relationship between changes in brain activities and sensory and motor functions using temporal interference stimulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in resting brain activity
Key secondary outcomes
Changes in sensory function (tactile, pain, and interoception)
Changes in motor function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Temporal interference stimulation to the insular cortex
Interventions/Control_2
Temporal interference stimulation to the primary somatosensory cortex
Interventions/Control_3
Transcranial alternating current stimulation to the insular cortex
Interventions/Control_4
Transcranial alternating current stimulation to the primary somatosensory cortex
Interventions/Control_5
Sham stimulation
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Participants who have given written consent to participate in this study
Key exclusion criteria
Participants with a history of psychiatric or neurological disorders
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naofumi |
| Middle name | |
| Last name | Otsuru |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
025-257-4448
otsuru@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Naofumi |
| Middle name | |
| Last name | Otsuru |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398, Shimami, Kita-ku, Niigata-City, 950-3198, Japan
TEL
025-257-4448
Homepage URL
otsuru@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata city, Niigata
Tel
025-257-4448
otsuru@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
